MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE PRECURVED CPV SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOG

Catalog Number 1B2040

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported, "on both occasions, was at the end of the procedures the tubing on each cuff pilot disconnected resulting in losing seal, as at the end no impact, or danger to the patient." no patient harm reported.The patient condition is reported as fine.

Event Description

It was reported "on both occasions, was at the end of the procedures the tubing on each cuff pilot disconnected resulting in losing seal, as at the end no impact or danger to the patient".No patient harm reported.The patient condition is reported as fine.

Manufacturer Narrative

(b)(4).Only the cuff pilot valve (cpv) and part of the inflation line was returned for evaluation.The partial returned sample was send to the manufacturing site for investigation.The manufacturing site reports: "the sample was tested and the joint between cpv and inflation line is still within specification".It was also reported that "there was a clean cut on the inflation line".The dhr was reviewed and no abnormalities were found.Based on the sample received, the complaint is confirmed.The cpv was within specification; however, the cut on the inflation line is slanted; indicating it had been cut with a sharp object.The complaint root cause is a non-manufacturing related or supplier related but the most probable root cause is unintentional user error.

• Brand Name: LMA FLEXIBLE PRECURVED CPV SIZE 4
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOG
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10826446
• MDR Text Key: 216183281
• Report Number: 9681900-2020-00020
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/28/2023
• Device Catalogue Number: 1B2040
• Device Lot Number: QRAC2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1